QA Specialist II

For Current Gilead Employees and Contractors:

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Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Gilead is seeking a candidate who has previous experience in pharma (ideally bulk processing and aseptic processing) and investigations experience. The ideal candidate would be investigating and writing investigation summary reports for deviations across all functions, including Manufacturing, QC, Validation, Engineering, Supply Chain, Maintenance, and Metrology. An impartial investigator with the ability to conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability.

This position will be reporting in office at the La Verne site.

Essential Duties and Job Functions:

Performs a variety of activities to ensure compliance with applicable regulatory requirements.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Participates in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives.
Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues for investigation support.
Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
Conducts or serves as lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products.
Works with operating entities to develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
Interfaces with contract manufacturers and suppliers to address documentation and compliance issues.
Normally receives general instruction on routine work, detailed instructions on new assignments.

Knowledge, Experience and Skills:

Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
Demonstrates audit and investigation skills, and report writing skills.
Demonstrates strong verbal, technical writing and interpersonal skills.
Demonstrates proficiency in Microsoft Office applications.

Basic Qualifications:

4+ years of relevant experience in a GMP environment related field and a BS OR 3+ years of relevant experience and an AA degree.
Prior experience in pharmaceutical industry is beneficial.

Preferred Experience:

QA experience preferred. Educational background in the sciences (Engineering, Biology, Chemistry).
Must have strong writing skills to present findings in a clear and concise manner.
Must be detail-oriented and able to demonstrate a high standard of integrity.
Must have a desire to demonstrate excellence by setting high standards

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community:

https://gilead.avature.net/Gilead

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

The salary range for this position is: $88,145.00 - $114,070.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact

careers@gilead.com

for assistance.

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For Current Gilead Employees and Contractors:

Please log onto your

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